[Edaily Reporter NA EUN-KYUNG ] EuBiologics Co., Ltd.(206650)announced on the 24th that its immune-enhancing platform, “EcML™,” has completed registration with the U.S. Food and Drug Administration (FDA) Drug Master File (DMF) and has been assigned an official registration number.

The newly registered Type IV DMF includes Chemical, Manufacturing, and Control (CMC) data such as EcML’s raw materials, manufacturing processes, and quality specifications. The company explained that this lays the groundwork for global developers to utilize this data when submitting Investigational New Drug (IND) applications and Biologics License Applications (BLAs) for vaccines incorporating EcML in the U.S.

EcML is an MPLA-class adjuvant that enhances the immune response to vaccines by activating toll-like receptor 4 (TLR4) in the body. Developed based on technology transferred from the Korea Institute of Science and Technology (KIST), the company stated that it has improved productivity, purity, and yield through a manufacturing process that directly produces EcML from the cell membranes of genetically modified E. coli.

EuBiologics Co., Ltd. is currently developing a shingles vaccine, a respiratory syncytial virus (RSV) vaccine, and an Alzheimer’s disease therapeutic vaccine incorporating EcML through its U.S. joint venture, EUPOP Life Sciences. The company plans to use this DMF registration as an opportunity to expand not only its own pipeline but also joint development and technology transfer collaborations with global pharmaceutical companies.

According to the company, it has secured a product portfolio capable of supplying not only EcML raw materials but also “ELS,” a liposome-based adjuvant formulation, in both liquid and freeze-dried forms. Based on this, the company’s strategy is to expand not only the supply of raw materials and formulations tailored to partners’ development needs but also its commercial-scale raw material supply business.

EuBiologics Co., Ltd. official stated, “This FDA DMF registration will serve as an opportunity to strengthen the foundation for the global development and commercialization of the EcML platform,” adding, “We will continue to grow our global immune enhancer platform business by expanding joint development and technology transfer with global pharmaceutical companies, as well as the supply of EcML and ELS products.”